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Directive for Certificate of Competence and Market Authorization of Fabric Face Mask (Directive No. 768/2021)

Ethiopian Food and Drug Authority768/2021

Summary

This directive establishes requirements for the Certificate of Competence and Market Authorization of Fabric Face Masks manufactured in Ethiopia. It outlines definitions, scope, registration procedures, manufacturing requirements, packaging and labeling standards, certificate of competence issuance, and administrative measures for non-compliance.

Who's affected

Local large-scale manufacturers of fabric face masks intended for community use, excluding those for medical purposes or produced by small and medium-scale manufacturers.

Action required

Manufacturers of fabric face masks must apply for registration with the Ethiopian Food and Drug Authority, submit required documentation, meet specified manufacturing and labeling standards, and obtain a Certificate of Competence before placing products on the market.

Key points

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  • Establishes Certificate of Competence and Market Authorization for fabric face masks.
  • Applies to local, large-scale manufacturers for community use.
  • Excludes medical masks and small/medium-scale production.
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    • Details registration, documentation, manufacturing, packaging, and labeling requirements.
    • Outlines procedures for obtaining a Certificate of Competence.
    • Specifies penalties including suspension/revocation of certificates and product recall.

Requirements

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  • Manufacturers must register with the Authority and obtain a market license.
  • Fabric face masks must meet Ethiopian national standards for filtration efficiency.
  • Manufacturers must provide proof of breathability resistance.
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    • Details on hydrocarbon chemical usage, especially antimicrobial chemicals, must be provided.
    • Materials in direct contact with skin shall not contain medicinal or biological ingredients.
    • Packaging materials must meet Ethiopian national standards and protect the product.
    • Labeling must be clear, truthful, non-fraudulent, and include specific information like brand name, type, manufacturer's address, and disclaimers.
    • An applicant for a Certificate of Competence must submit a written application, pay service fees, and provide a lease contract.
    • Manufacturing and storage rooms must be separate, disinfected, and free of pests.
    • A technical manager with relevant qualifications and experience is required.
    • A head of manufacturing and a head of quality control department must be appointed.
    • Employees must wear appropriate dust-free work safety clothing.
    • Manufacturers must report manufacturing details, type, quantity, and distribution information to the Authority.

Rights and permissions

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  • Manufacturers have the right to be issued a certificate of competency if they meet the requirements.
  • Applicants have the right to receive written feedback if they do not meet minimum requirements during inspection.

Restrictions

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  • The directive is not applicable to homemade fabric face masks or those made by small and medium-scale manufacturers.
  • Fabric face masks for medical purposes are excluded from this directive.
  • Labels must state that the product is not a medical mask and should not be used for medical purposes.
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    • Labels cannot claim the product has the ability to filter particulate matter or has antibacterial/antiviral services.
    • No text is allowed on the mask layer that is in direct contact with the user's skin.
    • Advertising and promotion must be clear, true, non-misleading, and consistent with product labeling.

Penalties

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  • The Authority may suspend or revoke a Certificate of Competence for contravening the directive's provisions.
  • Products manufactured in violation of the directive shall be recalled and disposed of from the market.

Objectives

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  • To set standards for the manufacture and market authorization of fabric face masks.
  • To ensure the quality and safety of fabric face masks for community use.
  • To prevent the spread of COVID-19 through standardized face mask production.

Organizations

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  • Ethiopian Food and Drug Authority

Legal references

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  • Proclamation No. 1112/2019 (Food and Medicine Administration Proclamation)
  • Article (2) of Proclamation No. 1112/2019
  • Article 65 of the Proclamation
Original sourcehttps://justice.gov.et/en/directives/directive-for-certificate-of-competence-and-market-authorization-of-fabric-face-mask-directive-no-768-2021/
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